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510(k) Data Aggregation
K Number
K173436Device Name
Luma Light System
Manufacturer
Luma Therapeutics
Date Cleared
2018-01-30
(88 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
Luma Therapeutics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LUMA™ Light System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), sebhoic dermatitis, and leukoderma on all skin types (I-VI).
Device Description
The Luma Light System is a phototherapy system intended to treat dermatological conditions such as psoriasis. The system includes a light module, an Android Nexus 4 phone, a software-based phone application (app), and a device charger. The light module contains light emitting diodes (LEDs), which create an array of narrowband UVB light centered at a wavelength between 300 - 320 nm. The light module attaches to a dressing applied to the patient's affected skin to allow for passive dosing of the lesion. This is a home use device intended to be used and operated by the patient (see technical specifications for environmental limitations). A physician will determine the dose and frequency of treatment. The app is then used by the patient to deliver treatments, provide treatment reminders and store data about prior treatments.
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